FDAFDA · Food and drugs·Recall number D-1296-2014
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Published May 7, 2014 · Recall initiated: April 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Distributor
- Nationwide
- Lot
- JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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